The New European Pharmacovigilance Legislation July 2012

In July 2012, new pharmacovigilance legislation will come into effect across the European Union (EU) as a result of changes set out in Regulation (EU)No1235/2010: and Directive 2010/84/EU. The legislation will be underpinned by a European Commission (EC) Implementing Measures Regulation and a series of modules on Good Pharmacovigilance Practice. Are you confident your pharmacovigilance operations will meet the EU’s latest expectations for compliance? Do you understand the processes needed to perform adequate risk assessment? Not knowing which systems and processes you must have in place for the new European pharmacovigilance requirements could have significant consequences for your product. You must be sure you have the understanding you need to be able to work to EU standards and have implemented regulatory requirements for signaling and risk management. This web seminar is designed to give pharmaceutical and biologic companies operating in the EU an introduction to the new European pharmacovigilance requirements. We will address: audits and inspections; ADR reporting and signal management; Periodic Safety Update Reports; risk minimization; Risk Management Plans; and post authorization studies.

Navigate the new EU regulatory requirements for drug safety

Process Adverse Events to meet EU requirements

Prepare for an European pharmacovigilance inspection

Drug Safety and Pharmacovigilance Personnel

Regulatory Affairs Professionals

Clinical Development Staff

Executives (including C-Level) with any legal responsibility for drug safety